Label: EMVITA 28- mandragora officinarum root, helleborus niger root, hyoscyamus niger, and sus scrofa cerebellum liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 66343-040-50 - Packager: RUBIMED AG
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated July 14, 2015
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- PURPOSE
- Ingredients
- TAMPER-EVIDENT
- Direction
- Warnings
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label
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INGREDIENTS AND APPEARANCE
EMVITA 28
mandragora officinarum root, helleborus niger root, hyoscyamus niger, and sus scrofa cerebellum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66343-040 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MANDRAGORA OFFICINARUM ROOT (UNII: I2XCB174VB) (MANDRAGORA OFFICINARUM ROOT - UNII:I2XCB174VB) MANDRAGORA OFFICINARUM ROOT 800 [hp_C] in 1 mL HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER ROOT 18 [hp_M] in 1 mL HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER 21 [hp_X] in 1 mL SUS SCROFA CEREBELLUM (UNII: 49NGK53TPQ) (SUS SCROFA CEREBELLUM - UNII:49NGK53TPQ) SUS SCROFA CEREBELLUM 21 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) 0.43 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66343-040-50 50 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 05/07/2015 Labeler - RUBIMED AG (480582035) Establishment Name Address ID/FEI Business Operations RUBIMED AG 480582035 MANUFACTURE(66343-040) Establishment Name Address ID/FEI Business Operations Omida AG 483268348 MANUFACTURE(66343-040)
